Nerve and muscle stimulation are used to treat a variety of medical conditions such as to reduce pain and to assist muscle and joint rehabilitation. Nerve stimulation has also been used for decades to control bladder function. Various approaches to bladder neuromodulation have been studied with stimulation of the pudendal, sacral, and tibial nerves found to be effective in controlling bladder function.
Percutaneous tibial nerve stimulation is a uniquely effective therapy for treating overactive bladder (OAB) and the associated symptoms of frequency, urgency, and urinary urge incontinence. It is a minimally invasive neuromodulation delivery method performed by placing a percutaneous needle electrode in the proximity of the tibial nerve, i.e., the stimulation site. A pulse generator and a transcutaneous electrode are electrically coupled to the needle electrode for providing current pulses to the stimulation site by passing current from the transcutaneous electrode to the percutaneous electrode.
One type of percutaneous tibial nerve stimulation system is described in U.S. Pat. No. 6,493,588 and is incorporated herein by reference. The system described in the '588 patent includes a pulse generator, a first lead wire electrically coupled to the pulse generator, a transcutaneous electrode electrically coupled to the first lead wire, a second lead wire electrically coupled to the pulse generator, and a percutaneous electrode needle electrically coupled to the second lead wire. During treatment, the transcutaneous electrode is positioned distal from the selected stimulation site on the surface of the skin. The percutaneous electrode needle is inserted through the skin in proximity of the tibial nerve. Current pulses traverse the internal stimulation site by passing from the transcutaneous electrode to the internal percutaneous electrode needle.
One problem with the system of the '588 patent was that the owners have had trouble implementing the system into a financially viable and profitable business model. In an attempt to solve this problem, the reusable lead wire system as described in the '588 patent was converted into a single use lead system as described, for example, in U.S. Pat. No. 7,536,226 and U.S. Pat. No. 8,046,082. While the advent of the single use lead system provides the ability to charge a patient/health care professional on a “per-treatment session” basis by requiring a new lead set to be used during each treatment session, the system requires perfectly operating leads to be wasted which leads to additional costs for the patient and manufacturer of the system. Further, the single use lead system is unable to determine whether a treatment session has been completed. Thus, if the treatment session was interrupted for any reason, the single use lead set would have to be replaced with a new lead set.
Another problem that exists with the Uroplasty devices is that the unit is bulky and requires two lengthy leads for connecting the electrodes to a hand-held controller unit.
What is needed therefore is a percutaneous tibial nerve stimulator system having reusable leads which provides the ability to charge a patient for each treatment session. In addition, a more compact and user friendly percutaneous tibial nerve stimulator system is desired.